A Community-University Approach to Preventing HIV

Mental Health Clinical Trial

Official title:

A Community-University Approach to Preventing HIV

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03938077
• Other study ID #: HUM00151011
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examine the feasibility and acceptability of delivering the S4E intervention to 20 African-American youths between the ages 16-21 in Flint, Michigan. The investigators will examine the preliminary efficacy of the S4E intervention in improving the uptake of HIV self-testing immediately post-intervention.

Description:

HIV is a significant public health concern in the US, and African American youth (defined as the adolescent and young adults 16-21 years of age) are disproportionately affected. Furthermore, HIV risk behaviors, including substance use and sexual risk behaviors are prominent. Despite the disproportionately high rates of HIV infection and risk behaviors in youth, few youth report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. To address these significant public health concerns, a mobile-health (mHealth) intervention, Storytelling 4 Empowerment (S4E) was developed for health clinic settings. S4E has demonstrated high feasibility, acceptability, and preliminary efficacy among youth in clinic settings. The proposed research will determine the feasibility and acceptability of delivering S4E via near peers, as well as determine the preliminary efficacy of S4E to improve HIV self-testing immediately post-intervention in a community sample (n=20) of at-risk youth ages 16-21 living in Flint, Michigan by conducting a phase I, one-arm pilot study to examine the feasibility and preliminary efficacy of S4E in improving the uptake of HIV self-testing immediately post-intervention. A University-Community approach was taken to employ principles of Community Based Participatory Research (CBPR) to determine the accessibility and acceptability of S4E when delivered by Near Peers.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 21 Years

Eligibility

Inclusion Criteria:

• 16-21 years of age

• Sexually Active

• African American

• Live in Flint Michigan

Exclusion Criteria:

• Report of prior psychiatric hospitalization by adolescent

• Visible cognitive impairment due to drug use

Related Conditions & MeSH terms

• Adolescent Behavior
• Alcohol Use
• Drug Abuse
• Drug Usage
• HIV Testing
• HIV/AIDS and Infections
• Mental Health
• Substance-Related Disorders
• Tobacco Use

Intervention

Device:
• Storytelling 4 Empowerment
S4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol & drug use, HIV & STIs, and tobacco prevention and cessation.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	YOUR Center	Flint	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cordova D, Alers-Rojas F, Lua FM, Bauermeister J, Nurenberg R, Ovadje L, Fessler K, Delva J, Salas-Wright CP, Council YL. The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care. Behav Med. 2018 Jan-Mar;44(1):36-47. doi: 10.1080/08964289.2016.1189396. Epub 2016 Jul 15. — View Citation

Cordova D, Bauermeister JA, Fessler K, Delva J, Nelson A, Nurenberg R, Mendoza Lua F, Alers-Rojas F, Salas-Wright CP; Youth Leadership Council. A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study. JMIR Mhealth Uhealth. 2015 Dec 18;3(4):e106. doi: 10.2196/mhealth.4620. — View Citation

Córdova D, Lua FM, Ovadje L, Fessler K, Bauermeister JA, Salas-Wright CP, Vaughn MG, Leadership Council Y. Adolescent Experiences of Clinician-Patient HIV/STI Communication in Primary Care. Health Commun. 2018 Sep;33(9):1177-1183. doi: 10.1080/10410236.2017.1339379. Epub 2017 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Near Peer-Youth Communication for Near Peers from baseline to immediately post-intervention	Completed by the Near Peer, Near Peer-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by Near Peers. Responses range from "1=strongly disagree," to "5=strongly agree," on a five-point Likert scale. A sample statement for Near Peers and youths is, " I encouraged the youth to express his or her thoughts concerning drug use behaviors."; The Adolescent Patient-Provider Interaction Scale will also be used to assess Near Peer- youth interaction for accessing sexual and reproductive health care (e.g., the Near Peer explained everything youth needed to know).	baseline and immediately post-intervention
Other	Change in Near Peer-Youth Communication for Youth from baseline to immediately post-intervention	Completed by the youth, Near Peer-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by Near Peers. Responses range from "1=strongly disagree," to "5=strongly agree," on a five-point Likert scale. A sample statement for Near Peers and youths is, "I was encouraged to express my thoughts concerning drug use behaviors."; The Adolescent Patient-Provider Interaction Scale will also be used to assess Near Peer- youth interaction for accessing sexual and reproductive health care (e.g., the Near Peer explained everything youth needed to know).	baseline and immediately post-intervention
Other	Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention	Youth's self-efficacy will be assessed using two scales, including the Condom Self-Efficacy Scale (19 items, a =.85), and Drug Use Resistance Self-Efficacy (24 items, a =.98). Responses range from "1=not sure at all," to "4=definitely sure," on a four-point Likert scale. A sample question for the youth is, "How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it?"	baseline and immediately post-intervention
Other	Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention	Youth's self-efficacy will be assessed using two scales, including the Condom Self-Efficacy Scale (19 items, a =.85), and Drug Use Resistance Self-Efficacy (24 items, a =.98). Responses range from "1=not sure at all," to "4=definitely sure," on a four-point Likert scale. A sample question for the youth is, "How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it?"	baseline and immediately post-intervention
Primary	Lifetime HIV Testing	At baseline we will assess binary outcome of participant's lifetime HIV testing and collect date of most recent HIV test using an item adapted from the Centers for Disease Control (CDC) Youth Behavior Risk Survey (YRBS). A sample question for youth is "Have you every been tested for HIV?". Responses consist of "1=Yes", "0=No", and "98=Refuse to Answer".	Baseline
Primary	HIV Self-Testing	Immediately post-intervention, we will assess the binary outcome of HIV self-testing using items adopted from Lightfoot and colleagues (2018).	Immediately post-intervention
Primary	HIV Self-Test Results Disclosure	Post-intervention we will asses the percentage of youth that disclose their HIV self-test results to the Near Peer.	Immediately post-intervention
Secondary	Change in Sexual Risk Beliefs from baseline to immediately post-intervention	Beliefs regarding sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is, "Condoms help prevent pregnancy." Responses range from "1=Strongly disagree" to "5=Strongly Agree".	baseline and immediatly post-intervention
Secondary	Change in Sexual Risk Attitudes from baseline to immediately post-intervention	Attitudes about sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is "If I used a condom, sex would not feel as good." Responses range from "1=Strongly disagree" to "5=Strongly Agree".	baseline and immediatly post-intervention
Secondary	Change in Future intentions regarding sexual risk from baseline to immediately post-intervention	Change in future intentions of sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is, "How likely is it that you will decide to have sex in the next 90 days?"." Responses range from "1=Very Unlikely" to "5=Very Likely".	baseline and immediatly post-intervention
Secondary	Linkage to Care and Prevention	The percent of youth who are referred to substance use, mental health, and sexual health services will be assessed.	immediately post-intervention
Secondary	Eligibility rates for the Near Peer	During the recruitment period of Near Peers, we will monitor and record the percentage of potential near peer participants who meet eligibility criteria to be enrolled in the study.	enrollment period pre-intervention
Secondary	Percent of Enrollment for Near Peer	During the recruitment period of Near Peers, we will monitor and record the percentage of those potential near peers eligible to participate who decide to enroll in the study.	enrollment period pre-intervention
Secondary	Intervention Completion Rates for Near Peer	Immediately post intervention we will assess the rate of intervention completion of Near Peers.	immediately-post intervention
Secondary	Eligibility rates for the Youth	Immediately post-intervention, we will assess the percentage of participants who meet eligibility criteria for our study.	enrollment period pre-intervention
Secondary	Percent of Enrollment for Youth	We will assess the percentage of those youth eligible to participate who are enrolled in the study.	enrollment period pre-intervention
Secondary	Intervention Completion Rates for Youth	Immediately post intervention, we will assess the rate of intervention completion of youth participants.	immediately post-intervention
Secondary	Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ)	Satisfaction is defined as how much the Near Peer enjoyed using the app and will be measured by the Client Satisfaction Questionnaire (CSQ). The CSQ is a eight item survey adapted from Larsen and colleagues (1979) that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alphas have ranged from 0.87 to 0.92. A sample question is "How would you rate the app you have received?". Responses range from "1=Poor" to "4=Excellent".	immediately-post intervention
Secondary	Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)	Acceptability is defined as how much the Near Peer enjoyed the intervention and will be measured by the Session Evaluation Form (SEF). The SEF is a 13-item survey, modified from Harper and colleagues (2008), that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alpha of SEF was 0.89. A sample question is "The session was enjoyable". Responses range from "1=Strongly Agree" to "4=Strongly Disagree".	immediately-post intervention
Secondary	Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ	Satisfaction is defined as how much the youth enjoyed using the app and will be measured by the Client Satisfaction Questionnaire (CSQ). The CSQ is a eight item survey adapted from Larsen and colleagues (1979) that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alphas have ranged from 0.87 to 0.92. A sample question is "How would you rate the app you have received?". Responses range from "1=Poor" to "4=Excellent".	immediately-post intervention
Secondary	Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)	Acceptability is defined as how much the youth enjoyed the interview session and will be measured by the Session Evaluation Form (SEF). The SEF is a 13-item survey, modified from Harper and colleagues (2008), that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alpha of SEF was 0.89. A sample question is "The session was enjoyable". Responses Range from "1=Strongly Agree" to "4=Strongly Disagree".	immediately-post intervention